BEUDAMED
    FDA Recall Open, Classified

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    Recall: Z-1763-2025 · Initiated May 2, 2025

    Recall

    Recall Number
    Z-1763-2025
    Event Number
    96771
    Firm
    ICU Medical, Inc.
    FEI Number
    3013319212
    Product Code
    PHC
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    May 2, 2025
    Posted
    May 14, 2025
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    Reason

    Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

    Action

    Firm began notifying consignees on May 2, 2025 via hand delivery of letters titled "Urgent Medical Device Correction." Issue 1: User receives an error if they attempt to define a Percentage Dose Change Increase limit between 60% and 99%. Customers were instructed to ensure all users or potential users of the software are made aware of the notification and proposed mitigations: Use Percentage Dose Change Increase values between 20% and 59% or between 100% and 500%. Pharmacists will not be able to use values from 60% to 99%. Issue 2: It is possible for an unauthorized user to bypass the reauthentication steps required to approve a drug library or delete a medication ruleset. Customers were instructed to ensure all users or potential users are made aware of the notification and proposed mitigation: Communicate with all users the need to log off after finishing a session before leaving the workstation and following cybersecurity best practices. ICU Medical is developing a LifeShield software update to correct both issues.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

    Quantity

    12 US, 3 OUS